Back to resultsThe Impact of Vitamin C on Postoperative Acute Kidney Injury in Risk Patients Undergoing Valvular Heart Surgery
Primary Purpose
Acute Kidney Injury
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Vitamin C
Control (Normal saline)
Sponsored by
About this trial
This is an interventional prevention trial for Acute Kidney Injury focused on measuring Postoperative acute kidney injury
Eligibility Criteria
Inclusion Criteria:
- Patients older than 20 years and undergoing elective valvular heart surgery whose preoperative acute renal failure score is ≥3 (moderate to severe risk).
Exclusion Criteria:
- Emergency operation
- Cardiogenic shock or ventricular-assist device (eg. ECMO, IABP)
- Severe chronic kidney disease (GFR(CKD-EPI) <30ml/min/1.73m2)
- Patients with past history of gout or renal stone or hyperoxaluria or cystinuria
- Hemolytic anemia due to pyruvate kinase deficiency or glucose-6-phosphate dehydrogenase deficiency
- Sicklemia or thalassemia
- Hemochromatosis
- Allergy to disodium ethylenediamine-tetraacetate or ascorbic acid
- Patients taking aspirin up to 3 days before surgery
- Patients taking antiepileptic drug or fluphenazine or steroid
- Patients taking vitamin C within a month of surgery
- Pregnant or lactating women
- Patients who cannot understand the informed consent (eg. Foreigner)
Sites / Locations
- Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute, Yonsei Cardiovascular Hospital, Yonsei University College of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control group
Vitamin C group
Arm Description
Participants in this group are administered IV normal saline.
Participants in this group are administered IV vitamin C diluted in normal saline.
Outcomes
Primary Outcome Measures
Postoperative acute kidney injury
Compare the incidence of postoperative acute kidney injury between the Vitamin C group and the control group according to KDIGO guideline.
Secondary Outcome Measures
Postoperative oxidative stress and vascular injury(Comparing the serum concentration)
Compare the serum concentration of Malondialdehyde, Thrombomodulin before anesthetic induction and after CPB cessation.
Postoperative oxidative stress and vascular injury(Comparing the serum concentration)
Compare the serum concentration of Malondialdehyde, Thrombomodulin before anesthetic induction and after CPB cessation.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04210453
Brief Title
The Impact of Vitamin C on Postoperative Acute Kidney Injury in Risk Patients Undergoing Valvular Heart Surgery
Official Title
The Impact of Vitamin C on Postoperative Acute Kidney Injury in Risk Patients Undergoing Valvular Heart Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 24, 2020 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In cases of cardiac surgery or sepsis which cause inflammation, oxidative stress, endothelial injury and vasoplegia, serum vitamin C concentration is sharply decreased. The anti-inflammatory and anti-oxidant effects of vitamin C and the effects of reducing vasoconstrictor use have been demonstrated in patients with sepsis and septic shock, however, the foregoing effects have not been validated in patients undergoing cardiac surgery.
In this study, investigators investigate the effect of intravenous vitamin C on the incidence of acute renal injury after valvular heart surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
Postoperative acute kidney injury
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Patients are divided into 2 groups, who are administered IV Vitamin C or who are administered IV normal saline.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Neither participants, all care providers, investigators nor outcomes assessors know the treatment allocations.
Allocation
Randomized
Enrollment
264 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Participants in this group are administered IV normal saline.
Arm Title
Vitamin C group
Arm Type
Experimental
Arm Description
Participants in this group are administered IV vitamin C diluted in normal saline.
Intervention Type
Drug
Intervention Name(s)
Vitamin C
Intervention Description
Participants in "Vitamin C group" are administered IV vitamin C diluted in 100 cc normal saline 1 day before surgery, at rewarming during surgery, 3 hours after surgery, and every 6 hours thereafter until postoperative 24 hours.
Intervention Type
Drug
Intervention Name(s)
Control (Normal saline)
Intervention Description
Participants in "Control group" are administered IV 100cc normal saline at the same timepoint as above.
Primary Outcome Measure Information:
Title
Postoperative acute kidney injury
Description
Compare the incidence of postoperative acute kidney injury between the Vitamin C group and the control group according to KDIGO guideline.
Time Frame
Postoperative 7 days
Secondary Outcome Measure Information:
Title
Postoperative oxidative stress and vascular injury(Comparing the serum concentration)
Description
Compare the serum concentration of Malondialdehyde, Thrombomodulin before anesthetic induction and after CPB cessation.
Time Frame
Before anesthetic induction (Baseline)
Title
Postoperative oxidative stress and vascular injury(Comparing the serum concentration)
Description
Compare the serum concentration of Malondialdehyde, Thrombomodulin before anesthetic induction and after CPB cessation.
Time Frame
5 minute after CPB cessation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients older than 20 years and undergoing elective valvular heart surgery whose preoperative acute renal failure score is ≥3 (moderate to severe risk).
Exclusion Criteria:
Emergency operation
Cardiogenic shock or ventricular-assist device (eg. ECMO, IABP)
Severe chronic kidney disease (GFR(CKD-EPI) <30ml/min/1.73m2)
Patients with past history of gout or renal stone or hyperoxaluria or cystinuria
Hemolytic anemia due to pyruvate kinase deficiency or glucose-6-phosphate dehydrogenase deficiency
Sicklemia or thalassemia
Hemochromatosis
Allergy to disodium ethylenediamine-tetraacetate or ascorbic acid
Patients taking aspirin up to 3 days before surgery
Patients taking antiepileptic drug or fluphenazine or steroid
Patients taking vitamin C within a month of surgery
Pregnant or lactating women
Patients who cannot understand the informed consent (eg. Foreigner)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hye Bin Kim
Phone
82-2-2224-1242
Email
KAKDDUGI@yuhs.ac
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hye Bin Kim
Phone
82-2-2224-1242
Email
KAKDDUGI@yuhs.ac
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Impact of Vitamin C on Postoperative Acute Kidney Injury in Risk Patients Undergoing Valvular Heart Surgery
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